First interim results of the PERFORM study evaluating palbociclib in combination with endocrine therapy for HR+/HER2- advanced breast cancer

Background 1^st-line standard of care for HR+/HER2- advanced breast cancer (ABC) patients (pts) is an endocrine-based (ET) CDK4/6 inhibitor therapy. High efficacy and safety were shown in clinical trials. The need for real-world data on treatment patterns, effectiveness and quality of life (QoL) is high. Additionally, data on the socioeconomic status (SES) and on treatment satisfaction are scarce.

Methods 1,900 pts receiving 1^st-line palbociclib/ET will be enrolled in the prospective non-interventional study PERFORM in 320 sites across Germany and Austria. Primary endpoint is progression-free survival. Secondary endpoints include treatment patterns, effectiveness, treatment expectation/satisfaction, SES and QoL. The first interim analysis was done 12 months after first patient in focusing on baseline characteristics, SES and treatment expectation/satisfaction.

Results Between 10/2020 and 09/2021, 209 of 342 enrolled pts were observed for >3 months and 179 pts were evaluable for analysis. Median age was 69 years, 99% were female and 90% postmenopausal. 64% presented with relapse at enrollment and 36% had de novo ABC. 51% of pts were married, 15% full-time employed and 11% part-time. Therapy benefits were expected by 82% of pts and bad side effects by 12% before 1^st-line treatment, 3 months after treatment start 49% reported better side effects than expected, for 51% benefits met the expectation and for 10% benefits exceeded the expectations.

Conclusion The first interim analysis of PERFORM shows a high treatment satisfaction after 3 months of treatment in 1^st-line palbociclib/ET treated pts. Furthermore, SES does not seem to be a barrier for palbociclib/ET treatment.

 

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Interessenskonflikt 

Ich erkläre als korrespondierender Autor, dass ich oder einer bzw. mehrere meiner Ko-Autoren während der letzten 3 Jahre wirtschaftliche oder persönliche Verbindungen im oben genannten Sinne hatten: Interessenskonflikt Details Full/Part-time employment: Leonie Berger, Anne Adams, Esther Glastetter. Speaker Bureau/Expert testimony: Thomas Fietz, Michael P. Lux, Michael Weigel. Shareholer/Stockholder/Stock options: Esther Glastetter. Honoraria (self): Michael P. Lux. Advisory/Consultancy: Michael P. Lux, Michael Weigel (AstraZeneca, Roche, Pfizer, GSK, Lilly), Achim Wöckel (AstraZeneca, Celegene, Eisai, Lilly, Novartis, Pfizer, Roche, MSD, Genomic Health, Pierre Fabre, Clovis, Oyanos). Leadership Role: Esther Glastetter, Michael P. Lux. Travel/Accomodation/Expenses: Michael P. Lux, Michael Weigel

Publikationsverlauf

Artikel online veröffentlicht:
21. Juni 2022